DAISY
Research type
Research Study
Full title
A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)
IRAS ID
1008163
Contact name
David Wright
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2023-504045-31
Research summary
Rheumatoid arthritis (RA) is an autoimmune and inflammatory disease, which means that immune system attacks healthy parts in individual’s body by mistake, and causes swelling, pain, and stiffness in joints.\n\nThe study drug, nipocalimab is an antibody* that targets a specific receptor (protein that binds to specific molecule) called neonatal fragment crystallizable receptor (FcRn). Nipocalimab blocks FcRn receptor and prevents binding of IgG, thereby resulting in decrease of IgG levels. Certolizumab, another study drug, binds to and blocks the activity of tumor necrosis factor alpha (TNF-alpha), that decreased joint inflammation resulting in decreased joint damage.\n*Antibody is a type of protein that can recognize and bind to antigens in the body. \n\nThe purpose of this study is to see how effective and safe the combination therapy of nipocalimab and certolizumab is compared to certolizumab alone in participants with moderately to severely active RA despite of earlier therapies.\n\nThis study will include male and female participants from 18 to 75 years old who have moderately to severely active RA and who has not responded to the earlier advanced therapy.\n\nThe study will be conducted in 3 periods:\n1. Screening period (up to 6 weeks): Participants will be screened to confirm if they can take part in study.\n2. Double-blind treatment period (up to 22 weeks): Participants will be randomly divided into 2 groups nipocalimab and certolizumab (combination therapy) and certolizumab alone. Participants receiving certolizumab will also receive placebo to maintain the blind.\n3. Follow-up period (up to 8 weeks): Participants will be monitored for their health after last dose of study drug until the study ends. \nParticipants will undergo study assessments and tests, such as blood tests and urinalysis. All side effects will be recorded until study ends (up to 36 weeks). The total study duration of study is approximately 9 months.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0721
Date of REC Opinion
16 Oct 2023
REC opinion
Further Information Favourable Opinion